The vendor presentations are provided as educational opportunities only and do not reflect any endorsement or recommendation by the SPL OTC Sub-team, SPL Process Team, SPL Leadership Team, or the FDA.
Question-and-Answer Document - Please view respective Discussion Pages for responses. New questions and issues to Marcia Howard, Paula Markert, and Devon Morgan for posting consideration.
OTC References: Active Ingredients and Monographs
[29-Sept-2009]Active ingredients by name
Active Ingredients by category
TERMINOLOGY UPDATES
[11-Feb-2009]The following two new section headings are now acceptable in SPL documents:
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
The section headings and associated LOINC codes are located here: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162057.htm
Special Events
None currently scheduled
Objective: Address questions and concerns regarding SPL that affect the OTC industry.
Leader: Vacant
Contact mhoward@chpa.org to join this group.
No Meeting/Teleconference schedule (calls scheduled as needed)
Next meeting:
TBD
2015 Call Summary Notes:
2011 Call Summary Notes:
Training Materials (not all inclusive):
Training Materials from SPL R4 Overview & Training - Over-the-Counter Drug Products (July 30, 2008):
Training Materials from SPL R4 Overview & Training - Over-the-Counter Drug Products (June 26, 2009)
Training Materials from SPL R4 Overview & Training - Over-the Counter Drug Products (July 8, 2009)
Training Materials from SPL R4 Training - Common Errors in SPL R4 Submissions (July 8, 2009)
OTC SPL Template* (Posted July 15, 2009)
*Note: Fictitious product label created by Pryia Samuel, CHPA
Instructions for viewing the file:
1. Copy zip file to location on computer.
2. Unzip the file
3. Open the SPL file
Vendor Presentations:
The vendor presentations are provided as educational opportunities only and do not reflect any endorsement or recommendation by the SPL OTC Sub-team, SPL Process Team, SPL Leadership Team, or the FDA.
Additional Information:
SPL Updates: Join FDA Data Standards Council's listserv. To join, select this link Sign up for email updates on this web page: http://www.fda.gov/ForIndustry/DataStandards/default.htm.
FDA Electronic Submissions Gateway: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
Links to SPL R4 Electronic Drug Establishment Registration and Drug Listing documents: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm (see heading entitled "SPL Guidance and Supporting Documents.")
Question-and-Answer Document - Please view respective Discussion Pages for responses. New questions and issues to Marcia Howard, Paula Markert, and Devon Morgan for posting consideration.
Section headings and LOINC codes for OTC content:
Question
What LOINC code should be used for an Ingredients Section?
Answer
The LOINC code for DESCRIPTION can be used for the Ingredients Section in an OTC label.
See FDA SPL Resources Page for the complete list of section LOINC codes and other terminologies.
Vendor Presentations and 2008, 2009 Call Summary docs